UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of simulation education for the corresponding nurse at the time of massive bleeding in the operating room
Title of the study (Brief title)	The effect of simulation education for the corresponding nurse at the time of massive bleeding in the operating room
Region	Japan

Condition
Condition	Mass bleeding
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of simulation education on nurse's correspondence during mass bleeding in the operating room.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Perform OSCE simulation for both groups and evaluate. For evaluation, comprehension level is evaluated by behavioral evaluation by checklist and comparison of knowledge tests before and after.
Key secondary outcomes	We will conduct a questionnaire and comprehension degree survey two weeks after the simulation and confirm the validity of the implementation time by seeing the change in understanding level over time.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	Intervention period is half day in both groups
Interventions/Control_2	The number of interventions was 5 in both groups
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	22 years-old <=
Age-upper limit	39 years-old >
Gender	Male and Female
Key inclusion criteria	It is targeted to those who were adopted in our hospital operating room in FY 2017 and who agreed among nurses who passed one year after entering the hospital
Key exclusion criteria	It does not include experienced nurse at the time of entering our hospital
Target sample size	10

Research contact person
Name of lead principal investigator	Ritsuko Murai
Organization	Nagoya University Hospital
Division name	Nursing department
Address	65 Tsurumai-cho, Showa-ku,Nagoya city
TEL	052-741-2111
Email	ritsu819@gmail.com

Public contact
Name of contact person	Mika Kitano
Organization	Nagoya University Hospital
Division name	Nursing department
Address	65 Tsurumai-cho, Showa-ku,Nagoya city
TEL	052-741-2111
Homepage URL
Email	sarupo-piyopiyo@umin.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

Funding Source
Organization	Nagoya University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 29 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 04 Month 21 Day
Anticipated trial start date	2018 Year 04 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 04 Month 20 Day
Last modified on	2018 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036786